Comparing the effects of intravenous ephedrine, of muscular ephedrine and of intradermal ephedrine in preventing hypotension in caesarean section patients with spinal anesthesia
This study is a double-blind clinical trial with random allocation between intervention and control groups with a sample size of 96 in executing cesarean section through spinal anesthesia. Inclusion criteria: 20- to 30years old mothers who participate in class 1 and 2 ASA, who do not have a history of high blood pressure. Exclusion criteria: participants in class 3 and 4 ASA; any history of hypertension and pre-eclampsia and eclampsia. The first group, 10 minutes prior to spinal anesthesia, receive 30 mg of muscular ephedrine in the deltoid. In the first group, 10 minutes prior to spinal anesthesia, 10 mg of intradermal ephedrine is injected in the forearm. In the third group, immediately after spinal anesthesia, 20 mg of intravenous ephedrine is injected and in the fourth group 2 ml of normal saline is injected immediately after spinal anesthesia. In addition to the effect of ephedrine injection in intramuscular, intravenous and intradermal ways to prevent hypotension, the present study also measures chills, nausea and vomiting. It is noteworthy that all patients participated in this project with informed consent.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092824233N1
Registration date:2016-01-30, 1394/11/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-30, 1394/11/10
Registrant information
Name
Hasan Zabetian
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5423 0010
Email address
dr.zabetian@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Jahrom University of Medical Sciences
Expected recruitment start date
2015-05-15, 1394/02/25
Expected recruitment end date
2016-10-31, 1395/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of intravenous ephedrine, of muscular ephedrine and of intradermal ephedrine in preventing hypotension in caesarean section patients with spinal anesthesia
Public title
Comparing the effects of intravenous ephedrine, of muscular ephedrine and of intradermal ephedrine in preventing hypotension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 20 to 30years old mothers who participate in class 1 and 2 ASA; tend to have spinal anesthesia; do not have a base systolic blood pressure more than 130 mmHg and less than 90 mmHg; do not have a history of high blood pressure and are consciously willing to participate in the project. Exclusion criteria: participants in class 3 and 4 ASA; patients with cardiovascular disease; people with tachycardia (over 100 beats per minute) and with bradycardia (less than 60 beats per minute); any history of hypertension, diabetes mellitus; patients with thyroid disease, using beta-agonists and beta blockers; preterm delivery; using banned drugs during pregnancy; preeclampsia and pre-eclampsia and eclampsia.
Age
From 20 years old to 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Jahrom University of Medical Sciences
Street address
Jahrom University of Medical Sciences, Motahhari Blvd
City
Jahrom
Postal code
Approval date
2015-05-13, 1394/02/23
Ethics committee reference number
IR.JUMS.REC.1394.006
Health conditions studied
1
Description of health condition studied
Hypotension induced by injection of intravenous ephedrine, of muscular ephedrine and of intradermal ephedrine
ICD-10 code
I95.2
ICD-10 code description
Hypotension due to drugs
Primary outcomes
1
Description
Blood pressure
Timepoint
Every 2.5 minutes to 10 minutes and then until 45 minutes every 5 minutes
Method of measurement
mmHg
Secondary outcomes
1
Description
nausea and vomiting
Timepoint
every 15 minutes
Method of measurement
Scale Alderet
2
Description
Shivering
Timepoint
Every 15 minutes
Method of measurement
Scale rossely & mahajan
Intervention groups
1
Description
In The third group received an intravenous drug, Immediately after the entry of women into the operating room 10 milliliters per kilogram of body weight Ringer will be administered through IV No. 18 for them. Then immediately after spinal anesthesia will be administered to the patient intravenously 20 mg ephedrine.
Category
Treatment - Drugs
2
Description
In The fourth group received a placebo, Immediately after the entry of women into the operating room 10 milliliters per kilogram of body weight Ringer will be administered through IV No. 18 for them. Then 2 ml of saline immediately after spinal anesthesia will be administered to any patient.
Category
Placebo
3
Description
In the second group received intradermal drug, Immediately after the entry of women into the operating room 10 milliliters per kilogram of body weight Ringer will be administered through IV No. 18 for them. Then 10 minutes before spinal anesthesia in the forearm intradermal injection of 10 mg of ephedrine will.
Category
Treatment - Drugs
4
Description
The first group received the drug muscle, Immediately after the entry of women into the operating room 10 milliliters per kilogram of body weight Ringer will be administered through IV No. 18 for them. Then 10 minutes before spinal anesthesia with 30 mg of ephedrine in the deltoid region will receive.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari Hospital
Full name of responsible person
Mohsen Farkhondehfal
Street address
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Jahrom University of Medical Sciences
Full name of responsible person
Kavoos Solhjo
Street address
Jahrom University of Medical Sciences, Motahhari Blvd.
City
Jahrom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Jahrom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mohsen Farkhondehfal
Position
Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Motahhari Blvd.
City
Jahrom
Postal code
Phone
+98 71 3840 7325
Fax
Email
Mohsen.farkhondehfal@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr.Hasan Zabetian
Position
Anesthesiologist
Other areas of specialty/work
Street address
Jahrom University of Medical Sciences, Motahhari Blvd.
City
Jahrom
Postal code
Phone
+98 71 5647 4254
Fax
Email
dr.zabetian@jums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mohsen Farkhondehfal
Position
Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Motahhari Blvd.
City
Jahrom
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)